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Biosimilar Applicants Get FDA Guide to Seek Swapping Rights

Nov. 19, 2020, 8:59 PM

Drug companies should specify in their applications for low-cost biologics if they want pharmacists to be able to switch out an expensive product for theirs without a doctor’s approval, according to a draft Q&A document the FDA published Thursday.

The Food and Drug Administration plans to tack these questions and answers onto another policy outline when they’re finalized, giving industry leaders a central list they can use to navigate the complicated biosimilar drug approval process. Biosimilars are cheaper versions of expensive brand drugs made from living cells, called biologics. They typically treat severe ailments, like cancer.

Thursday’s draft publication is ...

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